BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHETIC VALVE CONDUIT

    MDR report key: 1063350 · Received June 19, 2008

    Report

    Report Number
    6000002-2008-07680
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 2, 2008
    Report Date
    June 16, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K781999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER APPROXIMATELY AN IMPLANT DURATION OF 50 MONTHS, DUE TO UNK REASONS. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS BIOPROSTHETIC VALVE CONDUIT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4300 3A0366

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention